González Urbà, Pinart Mariona, Rengifo-Pardo Mónica, Macaya Antonio, Alvar Jorge, Tweed John A
Department of Dermatology, Research Unit for Evidence-based Dermatology, Hospital Plató, c/ Plato 21, Barcelona, Catalunya, Spain, 08006.
Cochrane Database Syst Rev. 2009 Apr 15(2):CD004834. doi: 10.1002/14651858.CD004834.pub2.
Pentavalent antimonial drugs are the most prescribed treatment for American cutaneous and mucocutaneous leishmaniasis. Other drugs have been used with varying success.
To assess the effects of therapeutic interventions for American cutaneous and mucocutaneous leishmaniasis.
We searched the Cochrane Skin Group Specialised Register (January 2009), the Register of Controlled Clinical Trials in The Cochrane Library (Issue 1,2009), MEDLINE (2003 to January 2009), EMBASE (2005 to January 2009), LILACS (from inception to January 2009), CINAHL (1982-May 2007) and other databases.
Randomised controlled trials (RCTs) assessing treatments for American cutaneous and mucocutaneous leishmaniasis.
Two authors independently assessed trial quality and extracted data.
We included 38 trials involving 2728 participants. Results are based on individual studies or limited pooled analyses. There was good evidence in:Leishmania braziliensis and L. panamensis infections:Intramuscular (IM) meglumine antimoniate (MA) was better than oral allopurinol for 28 days (1RCT n=127, RR 0.39; 95% CI 0.26, 0.58). Intravenous (IV)MA for 20-days was better than 3-day and 7-day IVMA plus 15% paromomycin plus 12% methylbenzethonium chloride (PR-MBCL) or 7-day IVMA (1RCT n= 150, RR 0.24; 95% CI 0.11, 0.50; RR 0.69; 95% CI 0.53, 0.90; RR 0.64; 95% CI 0.44, 0.92 respectively). Oral allopurinol plus antimonials was better than IV antimonials (2RCT n= 168, RR 1.90; 95% CI 1.40, 2.59; I(2)=0%).L. braziliensis infections:Oral pentoxifylline plus IV sodium stibogluconate (SSG) was better than IVSSG (1RCT n= 23, RR 1.66; 95% CI 1.03, 2.69); IVMA was better than IM aminosidine sulphate (1RCT n= 38, RR 0.05; 95% CI 0.00, 0.78) and better than IV pentamidine isethionate (1RCT n= 80, RR 0.45; 95% CI 0.29, 0.71). Intramuscular MA was better than Bacillus Calmette-Guérin (1RCT n= 93, RR 0.46; 95% CI 0.32, 0.65).L .panamensis infections:Oral allopurinol was better than IVMA (1RCT n= 58, RR 2.20; 95% CI 1.34, 3.60). Aminosidine sulphate at doses of 12 mg/kg/day and 18 mg/kg/day for 14 days were better than aminosidine sulphate 12 mg/kg/day for 7 days (1RCT n= 60, RR 0.23; 95% CI 0.07, 0.73; RR 0.23; 95% CI 0.07, 0.73 respectively). Oral ketoconazole for 28 days, oral miltefosine and topical PR-MBCL were better than placebo.
AUTHORS' CONCLUSIONS: Most trials have been designed and reported so poorly that they are inconclusive. There is a need for large well conducted studies that evaluate long-term effects of current therapies to improve quality and standardization of methods.
五价锑药物是治疗美洲皮肤利什曼病和黏膜皮肤利什曼病最常用的药物。其他药物的使用效果各异。
评估美洲皮肤利什曼病和黏膜皮肤利什曼病治疗干预措施的效果。
我们检索了Cochrane皮肤组专业注册库(2009年1月)、Cochrane图书馆中的对照临床试验注册库(2009年第1期)、MEDLINE(2003年至2009年1月)、EMBASE(2005年至2009年1月)、LILACS(自建库至2009年1月)、CINAHL(1982年 - 2007年5月)及其他数据库。
评估美洲皮肤利什曼病和黏膜皮肤利什曼病治疗方法的随机对照试验(RCT)。
两位作者独立评估试验质量并提取数据。
我们纳入了38项试验,涉及2728名参与者。结果基于个体研究或有限的汇总分析。在以下方面有充分证据:
肌肉注射(IM)葡甲胺锑(MA)治疗28天优于口服别嘌呤醇(1项RCT,n = 127,RR 0.39;95% CI 0.26,0.58)。静脉注射(IV)MA治疗20天优于3天和7天IV MA加15%巴龙霉素加12%苄索氯铵(PR - MBCL)或7天IV MA(1项RCT,n = 150,RR 0.24;95% CI 0.11,0.50;RR 0.69;95% CI 0.53,0.90;RR 0.64;95% CI 0.44,0.92)。口服别嘌呤醇加锑剂优于静脉注射锑剂(2项RCT,n = 168,RR 1.90;95% CI 1.40,2.59;I² = 0%)。
口服己酮可可碱加静脉注射葡萄糖酸锑钠(SSG)优于静脉注射SSG(1项RCT,n = 23,RR 1.66;95% CI 1.03,2.69);静脉注射MA优于肌肉注射硫酸氨基糖苷(1项RCT,n = 38,RR 0.05;95% CI 0.00,0.78)且优于静脉注射喷他脒异硫氰酸盐(1项RCT,n = 80,RR 0.45;95% CI 0.29,0.71)。肌肉注射MA优于卡介苗(1项RCT,n = 93,RR 0.46;95% CI 0.32,0.65)。
口服别嘌呤醇优于静脉注射MA(1项RCT,n = 58,RR 2.20;95% CI 1.34,3.60)。剂量为12 mg/kg/天和18 mg/kg/天的硫酸氨基糖苷治疗14天优于12 mg/kg/天治疗7天(1项RCT,n = 60,RR 0.23;95% CI 0.07,0.73;RR 0.23;95% CI 0.07,0.73)。口服酮康唑28天、口服米替福新和局部使用PR - MBCL优于安慰剂。
大多数试验的设计和报告质量很差,因此无法得出结论。需要进行大规模的高质量研究,以评估当前疗法的长期效果,从而提高方法的质量和标准化程度。